BEUDAMED
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    MERCURY VCO2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450249765·

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 26, 2024

    M5T INSTANT FEVER THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ALARIS PUMP MODULE

    FDA Adverse Event
    Death ·CARDINAL HEALTH 303, INC.·Product code FRN·April 19, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 3, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024